Internal Hemorrhoids Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal Application of Iferanserin (10 mg) as a 0.5% Ointment in Subjects With Symptomatic Internal Hemorrhoids
Primary Objective:
To evaluate the effect of iferanserin ointment on cessation of bleeding when administered
intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal
hemorrhoids.
Methodology:
Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group,
placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.
Study Treatment Duration:
Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12
months (open-label part of the study in which there will be a scheduled visit every three
months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be
treated with open-label iferanserin for 7 days followed by a 21-day follow-up period).
Criteria for Evaluation:
Primary Endpoint:
The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the
remainder of the treatment period (through Day 14).
Primary Objective:
To evaluate the effect of iferanserin ointment on cessation of bleeding when administered
intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal
hemorrhoids. Safety Secondary Objective To determine the safety of iferanserin ointment
administered intra-anally BID for 7 or 14 days in subjects with symptomatic internal
hemorrhoids.
Exploratory Objectives:
To evaluate the frequency of recurrence of bleeding in subjects with symptomatic internal
hemorrhoids. To evaluate time to bleeding recurrence in subjects with symptomatic internal
hemorrhoids. To evaluate efficacy of iferanserin ointment in the treatment of recurrence when
administered intra-anally BID for 7 days in subjects with symptomatic internal hemorrhoids.
To evaluate the parameters of the Symptom Satisfaction Questionnaire
Methodology:
Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group,
placebo-controlled part of the study. Extension: Multicenter, open-label part of the study.
Criteria for Evaluation:
Primary Endpoint:
The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the
remainder of the treatment period (through Day 14).
Secondary Endpoints:
Key Secondary Endpoints Cessation of itching by the end of Day 7 that persists for the
remainder of the treatment period (through Day 14). Cessation of pain by the end of Day 7
that persists for the remainder of the treatment period (through Day 14). Safety Secondary
Endpoints Adverse events (AEs). Serious Adverse events (SAEs). Physical examination.
Hematology, serum chemistry, and urinalysis. Vital signs. Electrocardiogram.
Exploratory Endpoints:
Bleeding recurrence rate of symptomatic internal hemorrhoids. Time to bleeding recurrence of
symptomatic internal hemorrhoids. Response to open-label iferanserin ointment in the
treatment of recurrence of symptomatic internal hemorrhoids. Overall improvement score for
the parameters of the Symptom Satisfaction Questionnaire.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01913158 -
Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
|
Phase 2 | |
Completed |
NCT01533363 -
Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
|
Phase 3 | |
Completed |
NCT03335774 -
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
|
Phase 2 |